Regulatory Guidance Monthly Review - February 2021

February 2021 


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Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA)  that are pertinent to the governance of clinical trials and drug, biologic, or medical device development and approval.   Below are the relevant links to updates provided for both COVID-19 related and non-COVID-19 related programs in February 2021.

 

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New FDA Guidance Documents:


Development of Monoclonal Antibody Products Targeting SARSCoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency Guidance for Industry (22 Feb 2021)

Download FDA Guidance

Emergency Use Authorization for Vaccines to Prevent COVID-19 Guidance for Industry (22 Feb 2021)

Download FDA Guidance

Investigational COVID-19 Convalescent Plasma Guidance for Industry (11 Feb 2021)

Download FDA Guidance

 

Blog Image-Regulatory Guidanc eMonthly_Regulatory Agencies in the News

 

FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine (27Feb2021)

Read FDA News Release

FDA Approves First Treatment for Molybdenum Cofactor Deficiency Type A (26 Feb2021)

Read FDA News Release

Coronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine (25Feb2021)

Read FDA News Release

Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants (22Feb2021)

Read FDA News Release

FDA Approves First in the World, First-of-Its-Kind Implant for the Treatment of Rare Bone Disease as a Humanitarian Use Device (17Feb2021)

Read FDA News Release

EMA releases guidance for COVID variant vaccine development (25Feb2021)

Read Article on RAPS.org

England and Canada diverge from US on cancer drug decisions (25Feb2021)

Read Article on RAPS.org

EMA plots earlier engagement with patient groups (19Feb2021)

Read Article on RAPS.org

Navigating the maze of electronic submissions at EMA (12Feb2021)

Read Article on RAPS.org

EU regulators expand use of remote source data verification in clinical trials (08Feb2021)

Read Article on RAPS.org

OCE year 4: Progress despite a pandemic (08Feb2021)

Read Article on RAPS.org


EMA, MHRA update on COVID vaccine pharmacovigilance (08Feb2021)

Read Article on RAPS.org

FDA outlines process for communicating record requests findings (02Feb2021)

Read Article on RAPS.org

New toolbox available for EMA's PRIME designees (02Feb2021)

Read Article on RAPS.org

CBER lays out scaled-down guidance agenda for 2021 (02Feb2021)

Read Article on RAPS.org

Inspections: GAO calls on FDA to plan for backlog, review alternatives (01Feb2021)

Read Article on RAPS.org


 

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